Intertek webinar:

Regulation (EU) 10/2011

on plastic food contact
materials - an update

Job Ridderbecks
Application Specialist Food Contact

Nadine Thomis
Business Development Manager
Regulatory Services
Webinar Series Schedule

EU Food Contact Regulation

November 10 | 11:00 AM EST

The Impact of the EU NIAS Regulations on the US FDA Final Articles

Indirect Food Additives Compliance
November 17 | 11:00 AM EST

Different Packaging Market: Compliance though the Supply Chain

December 1 | 11:00 AM EST

The Best Approach to Obtain FDA NO Objection Letter (NOL) for

Recycle Plastics and the Recycle Impact on Lifecycle Analysis
December 15 | 11:00 AM EST

Dispensing Machines FDA Food Contact Compliance

January 11 | 11:00 AM EST

Risk Assessments of Food Contact Materials that Migrate into Food

January 25 | 11:00 AM EST

Inks and Colorants: Global Food Contact Regulations and Migration

Studies Designed to Ensure Safe Use in Packaging
February 8 | 11:00 AM EST

Register at:
http://bit.ly/FCM-webinar
2
EU Plastics Regulation 10/2011

Agenda:
Framework Regulation EU 1935/2004
Regulation (EU) 10/2011:
Basic principles
Amendments including 6th amendment
Guidance documents
Declaration of Compliance
Q&A

3
EU landscape for food contact materials

Food contact materials and articles are regulated in Europe by:

Framework Regulation EC 1935/2004

General requirements for all food contact materials

Legislation on specific materials

Groups of materials and articles listed in the Framework Regulation

Directives on Individual Substances or groups of substances used in the

manufacture of materials and articles intended for food contact

National legislation covering groups of materials and articles for which EU

legislation is not yet in place

4
EU landscape for food contact materials

Framework Regulation (EC) No 1935/2004)

GMP 2023/2006/EC

Regenerated Active &

Ceramics Plastic Materials Recycled plastics Intelligent Materials
Cellulose film

(EU) No 10/2011 Nitrosamines in Certain epoxy

teats and soothers derivatives in coatings
Amendment 321/2011
Bisphenol A restrictions Amendment
Import Melamine and
polyamide kitchenware

Amendments
1282/2011,1183/2012 ,202/2014, 2015/174, 2016/1416

Non EU regulated food contact materials; paper & board,

glass, metals, printing inks, colorants, etc.
5
EU Framework Regulation 1935/2004

Is mandatory for all food contact materials including

packaging materials, kitchen utensils and equipment in the
food processing industry
Applicable for all regulated and not at EU level regulated
materials: plastics, paper & board, glass, metals, ceramics
etc.

Article 3: Materials and articles shall be manufactured in

compliance with Good Manufacturing Practice so that, under
normal or foreseeable conditions of use, they do not transfer
their constituents to food in quantities which could:
endanger human health
bring about an unacceptable change in the composition of
the food
bring about a deterioration in the organoleptic
characteristics thereof.

66
EU Plastics Regulation 10/2011

Commission Regulation (EU) No 10/2011 of 14 January 2011

on plastic materials and articles intended to come into contact with food

Most comprehensive specific measure, containing:

Compositional requirements
Specific provisions for certain materials and articles
Declaration of Compliance
Compliance testing
Transitional provisions
6 Annexes with detailed information on above topics

7
EU Plastics Regulation 10/2011

Scope

Plastic mono-layers
Plastic multilayers bound by adhesives
Plastic layers or coatings forming gaskets in caps & closures
Plastic layers in multi-material multi-layer materials

All plastics can be coated and/or printed

Contribution of substances from inks or coating layers to

the migration into the food needs to be taken into account
to fulfill the requirements of the (EU) 10/2011

88
EU Plastics Regulation 10/2011

Authorized substances

One positive list of authorized monomers and additives: Union list

Substances authorized but not included in the Union list
Colorants, Solvents, Aids to polymerisation, etc.
Have to comply with Article 3 of 1935/2004 and national law

Non intentional added substances (NIAS)

(impurities, reaction intermediates, decomposition products)

Subject to risk assessment by the manufacturer and needs to be performed based on

risk assessment principles, includes hazard assessment and exposure assessment.

Substances separated from the food by a functional barrier

Migration < 0,01 mg/kg (ND), not classified as CRM or substances in nano-form

99
EU Plastics Regulation 10/2011

Migration limits:

Overall Migration Limit (OML) measure for inertness of material

= sum of all substances that can migrate, limit 10 mg/dm
Specific Migration Limit (SML)
= quantity of one specific substance that migrates into food/food simulant.
Limit is specified in Union list, based on toxicological evaluation by EFSA
Maximum permitted quantity (QMA)
Applies to the residual content of the component into the food contact material.
Specified in Union list for some substances

Compliance with all of these limits is required to be compliant with

Regulation 10/2011 !

10
10
EU Plastics Regulation 10/2011

Migration testing Food simulants

Used to simulate various food types for testing purposes
Various food categories are linked to the different simulants
Broadly accepted (also outside Plastics Regulation)

Food type Food simulant

Aqueous food 10% Ethanol (simulant A)

Acidic food 3% Acetic acid (simulant B)
Alcoholic food ( 20%) 20 % Ethanol (simulant C)
Semi-fatty food
50 % Ethanol (simulant D1)
Alcoholic food (> 20%)

Fatty food Vegetable oil (simulant D2)

Dry food MPPO (simulant E)

11
11
EU Plastics Regulation 10/2011

Migration testing Test conditions: Test Contact time & temperature Intended food contact conditions

Overall migration: OM1

10d at 20 C Frozen, refrigerated

OM2 10d at 40C Long term storage including short term heating
7 standard test conditions
OM3
2h at 70 C Short term heating
2 alternative test conditions OM4 1h at 100 High temperature application

2h at 100C or at reflux or 1
(high temperature) OM5
h at 121C
High temperature application up to 121 C

OM6 4h at 100C or at reflux Any food contact conditions with food simulant
A,B,C at temp > 40 C
OM7
2h at 175 C High temperatures application with fatty foods

Specific migration:
Combination of contact times and temperatures
4 standardized conditions for exposure > 30 days
Frozen: 10 days 20C
Refrigerated: 10 days 40C
Storage 6 months RT: 10 days 50C
Storage > 6 months RT: 10 days 60C

12
12
EU Plastics Regulation 10/2011

Migration testing Specific migration testing

Specific Migration Limits specified in Union list
Substances to be tested based on composition of material
Over 900 substances listed ; several analytical techniques required to
determine the concentration of the used monomers/additives in the
food contact material or article

13
13
EU Plastics Regulation 10/2011

Screening Approaches:

can be used to limit the number of migration tests

Residual content & 100% migration calculation
Migration modeling: applying generally recognized diffusion
models. But information needs to be available
Replacing specific migration by overall migration
Substitute food simulants: now assigned in the 6th
amendment, but detailed information about test conditions
only in the Draft Guidance document

Note: if a material fails in the screening approach, a conclusion for non

compliance has to be confirmed by verification tests (migration tests with
regulated simulants)

14
EU Plastics Regulation 10/2011

Non Intentionally Added Substances (NIAS)

Impurities, reaction intermediates, decomposition products,
contaminations
Subject to risk assessment:
Risk assessment is responsibility of the manufacturer and needs
to be performed based on internationally accepted risk
assessment principles, includes hazard assessment and
exposure assessment

15
15
EU Plastics Regulation 10/2011 - Amendments

Since the implementation EFSA (European Food Safety Authority)

issued several scientific evaluations for substances which need to be
added to the positive list.

For a few substances the restrictions and/or specifications already

established in the past, need to be amended based on new scientific
evaluation by EFSA.

Additional evaluations covered by 5 amendments currently

For each amendment a transitional period is in place

One amendment is in place (EU 321/2011) regards the restriction of

the use of Bisphenol A in polycarbonate infant feeding bottles.

One amendment is in place (EU 284/2011) on kitchenware

(melamine and polyamide) imported from China or Hong Kong

16
16
6th Amendment: Regulation (EU) 2016/1416

The most important changes:

14 new substances evaluated by EFSA and added to the positive list

Substances with FCM No. 871, 1031 and 1052 listed in Annex I for
which a restriction (50 ppb) on the migration of oligomers (< 1000
Dalton) is laid down in that Annex shall only be used if a suitable
method of analysis for determining the migration of oligomers can be
provided. In future EFSA will provide test methods.

For caps, gaskets, stoppers and similar sealing articles, the specific
migration value shall be expressed in mg/kg using the actual volume
of food in the container (option to express in mg/dm2 removed)

Definitions of rubber not yet included

Substitute simulants introduced (95 % ethanol and iso-octane, MPPO

in case foreseeable use > 100C) in case testing with simulant D2 is
technical not feasible). But still no rules on test conditions!

17
6th Amendment: Regulation (EU) 2016/1416

Generic migration limit has been repealed

(>> 200 substances without SML)

Changes to the specific migration limits for metals:

aluminum : 1 mg/kg (newly added)
Zinc: 5 mg/kg (instead of 25)
Nickel: not yet included (to be expected in 7th amendment)

A provision has been added for testing specific migration with

only the worst-case simulant (based on scientifically proven)

Definition of hot fill included

Assignment of MPPO as food simulant for fresh and chilled fruit

and vegetables (CF = 10)

Assignment of simulant B (besides simulant A) for fresh peeled

or cut vegetables/fruit in case the pH < 4.5

18
6th Amendment: Regulation (EU) 2016/1416

Migration testing for Food Processing Equipment: it is allowed to use the

actual worst case processing conditions instead of the standardized
testing conditions

Transitional provisions:

Into force as on September 14th 2016

Plastic materials complying with the (EU)10/2011 as applicable before

Sep 14th may be placed on the market until September 14th 2017

The following provisions shall apply from September 14th 2018:

Migration limits for Zinc and Aluminum
The adjusted simulants for vegetables and fruits

19
Upcoming changes

EU commission notified draft regulation to WTO to lower the SML for

Bisphenol A: from 0.6 mg/kg to 0.05 mg/kg
Also applicable to varnishes and coatings
Expected entry into force: 2017
Upcoming guidance on migration testing postponed several times
7th amendment :
Revised limit for Nickel (0.02 mg/kg)
No OML restriction for dry food
section 8 of DoC (Annex IV) is proposed to be amended (food contact
surface area)
Modernize the scientific approach in evaluation studies: NIAS, Exposure,
etc.

2020
EU Plastics Regulation 10/2011 Guidance documents

Guidance documents:
1. EU guidance on Regulation 10/2011:

This Guidance document covers general aspects of the Plastics Regulation:

explanations on what is covered by the Plastics Regulation and what is not,

definitions of terms that relevant in the context of food contact materials and
articles,

function categories of additives and polymer production aids,

explanations which substances are included in the Union list,

explanations why substances are exempted from inclusion in the Union list and
applicable provisions for these substances,

21
21
EU Plastics Regulation 10/2011 Guidance documents

2. EU guidance on information in the Plastic Supply Chain:

The aim of the Declaration of Compliance (DoC)
The roles and obligations in the supply chain depends on the type of
product being delivered to the direct customer:
Chemical substances (monomers, additives, starting materials,
solvents,..)
Plastic intermediates (granulates, sheet, film, laminate
Non-plastic intermediates (ink, coating)
Final plastic material (ready to go into contact with food)
Covers information to be generated and exchanged in the supply
chain
Sharing of Adequate information on non-plastic intermediates (inks,
adhesives, coatings)

22
22
EU Plastics Regulation 10/2011 Guidance documents

3. Technical Guidelines for Migration Testing; DRAFT

Published by JRC (Joint Research Centre)
Covers a comprehensive guidance on migration testing (120 pages !)
Detailed guidance on sampling strategy (distinction official control
and compliance testing)
Comprehensive description on testing conditions and the differences
between compliance testing (verification tests) and screening
approaches
Alternative simulants for vegetable oils and selection of test
conditions for the alternative simulants (differences for poly-olefins
and non-poly-olefins)
Barrier properties of different plastics
Single side vs. total immersion vs. layer thickness of plastic

23
23
EU Plastics Regulation 10/2011 DoC

Declaration of Compliance (DoC)

Plastic food contact materials shall be accompanied by a written Declaration

of Compliance stating that they apply with the rules applicable to them
Provides the next one in the supply chain with relevant information necessary
to establish or check compliance of the article
Applies to the final article but also to intermediate stage up to starting
substances
A new DoC should be issued if there are changes in the composition or
production of the product that bring about changes in the migration
Supporting documentation (evidence) are all in-house documents on
which DoC is based and needs to be available to enforcement authorities
Adequate information for non-plastic parts
(adhesives,printing inks, coatings)

24
24
Regulatory Support in the Supply Chain

Monomer & Polymer

Manufacturing Regulatory

Specialty Products EHS

(Rubber, Resin, Coatings)

Master Batchers Testing

& Compounds

Product &
Packaging Manufacturer
Process

Risk assessment Ingredient Manufacturer

Regulatory support & consultancy

Laboratory testing Consumer
Products
Notification new substances

25
EU Plastics Regulation 10/2011

Thank you for your attention

nadine.thomis@intertek.com
job.ridderbecks@intertek.com

26